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Menopur 75 IU, (menotropins for injection), packaged as a) 5 single dose vials of Menotropins for...

FDA Drug Recall #D-0299-2021 — Class III — March 2, 2021

Recall Summary

Recall Number D-0299-2021
Classification Class III — Low risk
Date Initiated March 2, 2021
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Ferring Pharmaceuticals Inc
Location Parsippany, NJ
Product Type Drugs
Quantity 1,155,601 cartons/5 vials per carton 12546 physician samples

Product Description

Menopur 75 IU, (menotropins for injection), packaged as a) 5 single dose vials of Menotropins for injection, 5 single dose vials of 0.9% Sodium Chloride Injection, USP 2 mL, NDC 55566-7501-2; b) Professional Sample Kit: 3 single dose vials of Menotropins for injection, 3 single dose vials of 0.9% Sodium Chloride Injection, USP 2 mL, NDC 55566-7501-3; Rx Only, Manufactured for Ferring Pharmaceuticals Inc. Parsippany. NJ 07054. Diluent manufactured for Ferring Pharmaceuticals Inc.

Reason for Recall

Failed pH specifications: Out of Specification pH results for 0.9% Sodium Chloride, USP

Distribution Pattern

Distributed nationwide in the USA.

Lot / Code Information

Lots# a) P12585AC, Exp. Date 31-Mar-2020 P12677AA, Exp. Date 31-Mar-2020 P12678AA, Exp. Date 31-Jul-2020 P12679AA, Exp. Date 31-Jul-2020 P12680EA, Exp. Date 31-Jul-2020 P15461AA, Exp. Date 31-Jul-2020 P15462AA, Exp. Date 31-Aug-2020 P15463AA, Exp. Date 31-Aug-2020 P15870AA, Exp. Date 31-Aug-2020 P15872AA, Exp. Date 31-Aug-2020 P16099AA, Exp. Date 31-Aug-2020 P16100AA, Exp. Date 30-Sep-2020 P16101AC, Exp. Date 30-Sep-2020 P16248AA, Exp. Date 30-Sep-2020 P16770AA, Exp. Date 30-Nov-2020 P16771AA, Exp. Date 30-Nov-2020 R10623AA, Exp. Date 31-Jan-2021 R10624AA, Exp. Date 31-Jan-2021 R10980AA, Exp. Date 31-Jan-2021 R11085AA, Exp. Date 31-Jan-2021 R11086AA, Exp. Date 31-Jan-2021 R11088AA, Exp. Date 28-Feb-2021 R11343AA, Exp. Date 28-Feb-2021 R11416AA, Exp. Date 28-Feb-2021 R11417AA, Exp. Date 28-Feb-2021 R11418AA, Exp. Date 28-Feb-2021 R11419AA, Exp. Date 28-Feb-2021 R12100AA, Exp. Date 28-Feb-2021 R12101AA, Exp. Date 28-Feb-2021 R12102AA, Exp. Date 31-Mar-2021 R12263CA, Exp. Date 31-Mar-2021 R12264AA, Exp. Date 31-Mar-2021 R12598AA, Exp. Date 31-Mar-2021 R12599AA, Exp. Date 31-Mar-2021 R12858AA, Exp. Date 30-Apr-2021 R12859AA, Exp. Date 30-Apr-2021 R12860AA, Exp. Date 31-Jul-2021 R12861AA, Exp. Date 31-Jul-2021 R14321AA, Exp. Date 30-Nov-2021 R14753AA, Exp. Date 31-Jul-2021 R14865AA, Exp. Date 31-Jul-2021 R14866AA, Exp. Date 31-Jul-2021 R15132AA, Exp. Date 31-Aug-2021 R15133AA, Exp. Date 31-Aug-2021 R15330AA, Exp. Date 31-Aug-2021 R15331AA, Exp. Date 31-Aug-2021 R15332AA, Exp. Date 31-Aug-2021 R15333AA, Exp. Date 31-Aug-2021 R15969AA, Exp. Date 30-Sep-2021 R15970AA, Exp. Date 30-Sep-2021 R16231AA, Exp. Date 30-Sep-2021 R16379AA, Exp. Date 31-Oct-2021 R16403AA, Exp. Date 31-Oct-2021 R16405AA, Exp. Date 31-Oct-2021 R16660AA, Exp. Date 31-Oct-2021 R16696AA, Exp. Date 30-Nov-2021 R16770AA, Exp. Date 31-Oct-2021 R17019AA, Exp. Date 31-Oct-2021 R17020AA, Exp. Date 30-Nov-2021 R17148AA, Exp. Date 30-Nov-2021 S11615AA, Exp. Date28-Feb-2022 S11616AA, Exp. Date 28-Feb-2022 S11617AA, Exp. Date 28-Feb-2022 S11618AA, Exp. Date 28-Feb-2022 S11619AA, Exp. Date 28-Feb-2022 S11620AA, Exp. Date 28-Feb-2022 S11621AA, Exp. Date 28-Feb-2022 S11623AA, Exp. Date 28-Feb-2022 S12026AA, Exp. Date 31-Mar-2022 S12413AA, Exp. Date 31-Mar-2022 S12436AA, Exp. Date 31-Mar-2022 S12437AA, Exp. Date 30-Apr-2022 S12438AA, Exp. Date 31-May-2022 S12439AA, Exp. Date 31-May-2022 b) Physician Samples P16101AA, Exp. Date 30-Sep-2020 R15332AC, Exp. Date 31-Aug-2021 S11625AA, Exp. Date 28-Feb-2022

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Frequently Asked Questions

Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects to FDA MedWatch at 1-800-FDA-1088.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.

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